Good Clinical Practice Guide

Contents include: 8 role and responsibilities of the sponsor 8 how to take a proportionate approach to trial management, including risk assessment 8 regulatory and ethical considerations 8 pha

management of investigationa

data management and statistics activities 8 roles and responsi

The Go

Foreword ix 01 Acknowledgements xi 01 Feedback xii 01 Abbreviations xiii 01 Preface xvii 01 Introduction xx 11 Chapter 1 Sponsor oversight 1 12 1.1 Sponsors 3 12 1.2 Clinical trial